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jetstream g3 system

Pathway Medical Technologies

Summary: The Jetstream G3 System is a mechanical thrombectomy and atherectomy device used to remove arterial plaque and thrombus. It is primarily used by interventional cardiologists and vascular surgeons in hospital settings.

FDA Clearance Information

Pathway 510K
Number K093456 ↗
Decision Date December 1, 2009
Product Code MCW
Device Class Class 2
Evidence 18 studies

The Jetstream G3 System was cleared through the FDA's 510(k) pathway on December 1, 2009. Manufactured by Pathway Medical Technologies, it is classified as a Class 2 medical device.

What It Is

The Jetstream G3 System is a rotational atherectomy device designed to remove atherosclerotic plaque and thrombus from peripheral arteries. It features a catheter with a rotating cutting tip that debulks and aspirates material from the arterial wall. This device is particularly useful for treating peripheral artery disease (PAD) and improving blood flow in occluded vessels.

Clinical Applications

The Jetstream G3 System is commonly used in interventional cardiology and vascular surgery to treat peripheral artery disease, especially in the lower extremities. It is suitable for use in hospital catheterization labs and outpatient vascular centers. The device is beneficial for patients with significant arterial blockages that are not amenable to balloon angioplasty alone.

Indications for Use

The Jetstream G3 System is indicated for patients with peripheral arterial disease, particularly those with significant plaque buildup or thrombus in their arteries. It is used to restore blood flow by removing these obstructions.

Practical Considerations

The Jetstream G3 System comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires a power console for operation. Proper technique involves careful navigation and controlled rotation to minimize vessel trauma.

Related Literature

The Jetstream G3™ Calcium Study focused on the device's effectiveness in treating calcified arterial lesions. While specific details and results are not available, such studies typically assess safety and efficacy in debulking calcified plaque. Limitations may include small sample sizes or lack of long-term follow-up data.

Linked Studies (18)

PubMed • 2025

Jetstream Atherectomy with Paclitaxel-Coated Balloons: 3-Year Outcomes of the Prospective Randomized JET-RANGER Study.

The International journal of angiology : official publication of the International College of Angiology, Inc

RCT View Source →
PubMed • 2025

Insights From the FDA's MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

JETWING technique: Combination therapy of JETSTREAMⓇ and aggressive wire recanalization in calcified atheroma and dilatation technique for eccentric heavy calcified plaques using WINGMAN for insertion of protection wire.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

View Source →
PubMed • 2023

Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study.

Vascular health and risk management

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study.

Vascular health and risk management

RCT|prospective View Source →
PubMed • 2022

Jetstream Rotational Atherectomy and Drug Coated Balloon Angioplasty with In Stent Re-stenosis and Occlusions. A Two Centre Study.

European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery

View Source →
PubMed • 2021

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021

Jetstream Atherectomy in Treating Femoropopliteal In-Stent Restenosis: Meta-Analysis of the JETSTREAM-ISR and JET-ISR Trials.

The Journal of invasive cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes.

Annals of vascular surgery

Other View Source →
PubMed • 2019

Jetstream Atherectomy System treatment of femoropopliteal arteries: Results of the post-market JET Registry.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015

JETSTREAM Atherectomy: A Review of Technique, Tips, and Tricks in Treating the Femoropopliteal Lesions.

The International journal of angiology : official publication of the International College of Angiology, Inc

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2012

Successful management of lower extremity distal embolization following percutaneous atherectomy with the JetStream G3 device.

The Journal of invasive cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2009

Use and abuse of atherectomy: where should it be used?

Seminars in vascular surgery

RCT|prospective|retrospective|case Series|other View Source →
ClinicalTrials.gov

A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System

View Source →
ClinicalTrials.gov

JetStream Atherectomy for the Treatment of In-stent Restenosis

View Source →
ClinicalTrials.gov

Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA

View Source →
ClinicalTrials.gov

The Jetstream (JET) Post-market Registry

View Source →
ClinicalTrials.gov

The Jetstream G3™ Calcium Study

View Source →

Frequently Asked Questions

What is the Jetstream G3 System used for?

The Jetstream G3 System is used for removing plaque and thrombus from peripheral arteries, particularly in patients with peripheral artery disease.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons typically use the Jetstream G3 System.

What are the FDA-cleared indications?

The device is indicated for removing arterial plaque and thrombus to restore blood flow in patients with peripheral artery disease.

Related Device Categories

Mechanical Thrombectomy Arterial Atherectomy Devices
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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